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Neural Tube Defects clinical trials

View clinical trials related to Neural Tube Defects.

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NCT ID: NCT04135274 Completed - Neural Tube Defects Clinical Trials

Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Neural Tube Defects?

Start date: January 1, 2015
Phase:
Study type: Observational [Patient Registry]

We aimed to investigate whether Neutrophil Lymphocyte Ratio is a Prognostic Factor of Sepsis in Newborns with operated Neural Tube Defects?

NCT ID: NCT03936322 Active, not recruiting - Spina Bifida Clinical Trials

Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study

Start date: May 7, 2019
Phase: N/A
Study type: Interventional

Researchers are studying a new minimally invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and at the same time adequate closure of the fetal spina bifida defect.

NCT ID: NCT03856034 Recruiting - Spina Bifida Clinical Trials

Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele

Start date: November 2, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.

NCT ID: NCT03794011 Active, not recruiting - Neural Tube Defects Clinical Trials

Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study

Start date: December 18, 2018
Phase: Phase 1
Study type: Interventional

The purpose of the study is to compare the maternal, fetal and neonatal outcomes of a cohort of 60 patients in whom a multilayer closure with a Durepair patch is performed with a prior cohort of patients in whom a standardized repair without patch (n = 32) was performed using the same minimally invasive fetoscopic repair technique. The hypothesis is that there will be a thicker repair (as measured by MRI at 6 weeks post surgery) and less MMC repair dehiscence and/or CSF leak with the patch repair.

NCT ID: NCT03544970 Completed - Fetal Anomaly Clinical Trials

An Audit of the Posterior Fossa Characterization in Open Spina Bifida Based on Tertiary Center Experience

Start date: April 1, 2017
Phase:
Study type: Observational

Brain stem and posterior fossa measurements in spina bifida aperta fetuses to compare them with normal population. Additionally, Describe the difference between pre- and postoperative findings.

NCT ID: NCT03351634 Not yet recruiting - Clinical trials for Neurogenic Bladder Due to Spinal Dysraphism

EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.

BPUA
Start date: December 30, 2017
Phase: N/A
Study type: Interventional

Urinary continence is still a difficult goal to achieve in neurogenic bladder patients. Conservative treatment of neurogenic urinary incontinence using clean intermittent catheterization in conjunction with pharmacological therapy, notably anticholinergic medication +/- adrenergic agents, may produce continence in a variable number of patients. In other patients, reconstructive surgery of the bladder and/or bladder neck is necessary to achieve urinary continence. Surgical treatment options to increase bladder outlet resistance in patients with neurogenic bladder include injection of bulking agents around the bladder neck, bladder neck reconstruction, fascial sling procedures and Artificial Urinary Sphincter. The Adjustable Continence Therapy system (ACT) or periurethral adjustable balloons are a minimally invasive device consisting of two volume-adjustable balloons implanted periurethrally at the bladder neck as a method of augmenting titration for urethral coaptation. Adjustable means that such system would be adaptable to the individual clinical condition. Originally conceived and developed as a treatment for female stress urinary incontinence, the technique has been then adapted and balloons were globally developed for the use in postprostatectomy incontinence. The published success rate in male after prostatectomy and in women was respectively 56 to 92% and 60 to 83%. The investigators hypothesize that the use of ACT for treating incontinence in children secondary to neurogenic sphincter incontinence could compress the urethra or the bladder neck, acting as an extrinsic occlusive system increasing passive and dynamic urethral and bladder resistance. Goal of the study: To prospectively assess the efficacy and safety of periurethral adjustable balloons in the treatment of neurogenic incontinence in children with spinal dysraphism. Material and methods : A prospective study will be performed at La Timone Enfants hospital and La Nord hospital in Marseille, France. Boys and girls at least at school age (5 or 6 years) with neurogenic incontinence due to outlet issues (low detrusor leak point pressure and low stress leak point pressure) with spinal dysraphism will be recruited. The ACT balloon is an implantable medical device developed and furnished for free by Uromedica (Irvine, CA, USA). The procedure is performed under general anaesthesia using the same implantation technique as published in adult population.

NCT ID: NCT03315637 Recruiting - Hydrocephalus Clinical Trials

Fetal Endoscopic Surgery for Spina Bifida

FESSB
Start date: January 2015
Phase: N/A
Study type: Interventional

This study aims to assess the feasibility to perform a fetoscopic prenatal repair of an open neural tube defect, and secondly to assess the maternal, fetal and neonatal outcomes.

NCT ID: NCT03262844 Recruiting - Clinical trials for Tethered Cord Syndrome

Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome

Start date: June 16, 2017
Phase: N/A
Study type: Interventional

Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a series of neurological dysfunctions and deformities attributable to abnormally increased tension on the spinal cord, which is lacking effective treatment to relieve the symptoms and prevent progression. Dr. Shi recently proposed a new technique as nerve root axial decompression surgery, which is also called capsule surgery, to treat patients with TCS. Yet, the effectiveness and safety should be further studied. Purpose: The aim of this study is to compare the effectiveness and safety of clinical outcomes between capsule surgery and conservative treatment in patients with TCS. A study hypothesis is that outcomes will be improved after capsule surgery. Methods: This study is a randomized clinical trial with a two-factor (2x7) research design. The TCS patients will be randomly assigned in one of the two treatment groups: capsule surgery and conservative treatment. Seven outcome measures will be collected pre-operative for baseline, and then at1, 12, 24, 48, and 96 weeks post-operative follow-up visits, including: International Consultation on Incontinence Modular Questionnaire Short Version (ICI-Q-SF), Rintala Score, a new developed Chinese version of questionnaire, Oswestry disability index (ODI), SF-12, foot function index (FFI) and Pirani score. Urodynamic testing, bladder ultrasonography, electromyogram, muscle strength and sensation of lower limbs will be obtained before and post treatment, to determine the patient`s function of lower limbs. The investigator performing the outcome measures will be blinded to group assignment, and therefore will not participate in treatment. After randomization, the conservative group will be followed up in the outpatient clinic. The capsule surgery group will receive the nerve root axial decompression surgery (capsule surgery). Data Analysis: Two 2x7 MANOVAs with repeated measures will be used to examine the differences in the seven measures between groups and at the five different time frames with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the differences in the urodynamics and muscle strength data over time and between groups.

NCT ID: NCT03198819 Recruiting - Clinical trials for Postoperative Infection Rates

Powder Topical Rifampicin on Reducing Infections After Neural Tube Defect Surgery in Infants

Start date: August 2016
Phase: N/A
Study type: Observational

The correct timing and technique of neural tube defect (NTD) repairs significantly decreases the morbidity and mortality of NTD cases. However, infections related to the surgery are still common. We investigated the effects of topical rifampicin (RIF) combined with routine prophylaxis in newborns with open NTD.

NCT ID: NCT03090633 Active, not recruiting - Spina Bifida Clinical Trials

Fetoscopic Repair of Isolated Fetal Spina Bifida

Start date: May 11, 2017
Phase: N/A
Study type: Interventional

The purpose of this investigation is to evaluate maternal and fetal outcomes following fetoscopic repair of fetal spina bifida at the Johns Hopkins Hospital. The hypothesis of this study is that fetoscopic spina bifida repair is feasible and has the same effectiveness as open repair of fetal spina bifida, but with the benefit of significantly lower maternal and fetal complication rates. The fetal benefit of the procedure will be the prenatal repair of spina bifida. The maternal benefit of fetoscopic spina bifida repair will be the avoidance of a large uterine incision. This type of incision increases the risk of uterine rupture and requires that all future deliveries are by cesarean section. The use of the minimally invasive fetoscopic surgical technique may also lower the risk of preterm premature rupture of membranes and preterm birth compared to open fetal surgery. Finally, successful fetoscopic spina bifida repair also makes vaginal delivery possible.